Services

Lyophilization

Freeze-drying is the specialism, and the thread running through most of my work.

• Cycle development and qualification

  Building a cycle on QbD and QRM principles rather than trial and error, then demonstrating it delivers the intended shelf temperature and pressure profile across the load, including worst-case positions.

• Performance equivalence

  The case that two or more dryers are interchangeable for a given product, so production planning is not locked to one unit.

• Cycle transfer

  Moving a validated cycle between units, sites or dryer generations, and identifying up front where the equipment difference will actually bite.

• Container closure systems

  How the closure changes what the cycle can do — including the move to plastic press-fit systems, which shortens cycles and allows direct in-chamber capping.

Commissioning and qualification

Equipment and utilities from user requirements to a signed qualification file: URS, design qualification, factory and site acceptance testing, then IQ, OQ and PQ. Filling lines, isolators, freeze-dryers and the utilities behind them.

This extends to cleaning validation and sterilization validation for complex CIP and SIP equipment, which is usually where a qualification programme runs into trouble.

I have led C&Q teams at the largest capital scale this industry builds at, so I am comfortable with the governance and reporting that comes with a project of that size — as well as with a single machine in an existing plant.

Aseptic processing and containment

Contamination control strategy and aseptic process design under the revised Annex 1, for injectables, lyophilisates, pre-filled syringes and large volume parenterals.

Fifteen years of that work has involved highly potent compounds and cytotoxics, where the cross-contamination strategy shapes the facility rather than sitting on top of it.

CMC and pharmaceutical development

Formulation and manufacturing process development from early phase through to commercial supply, covering both drug substance and drug product. Scale-up, process validation, and continued process verification once routine production starts.

Dosage forms: injectables and lyophilisates, pre-filled syringes, nasal sprays, large volume parenterals, and oral solids from coated tablets to hard and soft capsules.

I have run CMC for a clinical-stage sponsor as well as delivering it inside CDMOs, so I can sit on either side of a development programme.

Technology transfer

Products and processes moving between sites, between scales, or between organisations. Feasibility and technical studies, the transfer package, systematic project and product risk analysis, and the life cycle management plan that follows.

Where the transfer crosses a company boundary, I can also work on the contractual frame around it — master supply, development and technical quality agreements — having negotiated these from both the CDMO and the sponsor side.

QbD, risk management and training

Quality by Design and quality risk management implemented as something a team uses, not a binder it files. Design of experiments, critical quality attribute and critical process parameter definition, control strategy, and the statistical tools underneath.

I was one of three co-authors of a global QbD policy for new drug product development at a top-twenty pharmaceutical company, and I deliver this as training as readily as as consultancy.

Interim management and mission cover

Freelance cover as C&Q manager, qualification or validation lead, technology transfer lead or development lead, on a defined mission — for a project peak, a parental leave, or a gap between hires.

Engagements run on a day rate, on site or hybrid. I have held line management roles up to fifteen direct reports and a group of a hundred and twenty across four sites, so an interim role with real reporting responsibility is familiar ground.

Discuss a mission